Treatment Patterns in Atherosclerotic Cardiovascular Disease Patients and Familial Hypercholesterolemia Patients: A Database Cohort Study in the US†

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<h3>Lead Author's Financial Disclosures</h3> R.L. is an employee of Novartis Pharma AG, Basel, Switzerland. <h3>Study Funding</h3> None. <h3>Background/Synopsis</h3> There is currently little real-world research examining lipid-lowering treatments (LLT) treatment patterns in atherosclerotic cardiovascular disease (ASCVD) patients, and the associated change in LDL-C lab results. <h3>Objective/Purpose</h3> To describe the real-world treatment patterns and LDL-C outcomes in ASCVD patients with hypercholesterolemia (ASCVD-H) and patients with familial hypercholesterolemia (FH) in the United States (US). <h3>Methods</h3> Patients were identified from Optum's de-identified Clinformatics Data Mart database (2007-2019) in the US. Hypercholesterolemia was defined if patients had a recorded diagnosis, were prescribed LLT or had LDL-C levels of ≥70 mg/dL for ASCVD-H and ≥100mg/dL FH, anytime within 6 months before and 3 months after index date. Patients had to have ≥1 year follow-up after index date for the persistence and adherence analysis. Index date was first ASCVD encounter or FH diagnosis during the identification period (1/07/2015-31/12/2018). <h3>Results</h3> 1,424,893 patients with ASCVD-H (50% females) and 47,268 patients with FH (54% females) with a mean (SD) age of 72 (11) years and 64 (17) years, respectively, were included. At index date, statins monotherapy was the most commonly prescribed LLTs reported in 64% (ASCVD-H) and 51% (FH) patients. In patients with uncontrolled LDL-C (≥70mg/dL) and ASCVD-H or FH, 52.4% or 41.1% were receiving statins monotherapy while 38.5% or 48.9% respectively were not receiving any LLT. Out of 29,353 ASCVD-H patients receiving statins combinations with any drug, 18,372 (63%) were still uncontrolled despite 78.5% patients being adherent. <h3>Conclusions</h3> This data suggests low uptake of non-statins LLTs. Still 77% of ASCVD-H and 51% of FH patients remain with uncontrolled LDL-C, regardless of treatment received. Increased adherence only showed a small reduction in the proportion of patients with uncontrolled LDL-C suggesting an unmet need.